Human Subjects/IRB

Physician Clearance Policy

Physician Clearance Policy

Effective Date:02-02-2021
Revision Date:

I. Purpose

To provide a rationale for requiring physician clearance for certain participant populations prior to enrolling in a study, and describe all procedures associated with requesting physician clearance.

II. Policy Statement

In certain instances, the Institutional Review Board (IRB) may require researchers to request that an individual be “cleared” for participation prior to enrolling in a study. This step is most often required when the IRB is concerned for the safety of a subset of participants and mandates that certain individuals or class of individuals consult a medical professional, in most cases the individual’s Primary Care Provider, prior to being enrolled in a study.

III. Scope

There is no specific set of procedures in a protocol that may trigger the IRB to mandate physician clearance, the requirement will issue from the specifics of the study, the targeted population, and concerns arising during IRB deliberations. The IRB will inform researchers when the requirement to obtain a formal, signed physician clearance is a requirement for a protocol.

IV. Definitions

Physician clearance: A formal document signed by a medical professional attesting that an individual may safely participate in the study described in that document (please see attached Physician Clearance Template)

Physician: Unless otherwise noted, the IRB expects the physician to be the individual’s Primary Care Provider; however, physician clearance can be delegated to another medical professional duly authorized to provide medical advice, including a study physician.

V. Implementation

During the protocol review process, the IRB will communicate to researchers the need to acquire physician clearance for certain participants. The IRB will provide a Physician Clearance Template form which will be the only authorized manner in which the physician clearance will be recorded. Researchers will have the option of having potential participants approach their own physician(s) with the form and request physician clearance to participate in the research described. With participant permission, the researcher may also contact the physician(s) directly to request the signed clearance.

With regards to multi-year longitudinal studies, the IRB will request that researchers renew physician clearance annually. To clarify, researchers must request that the Physician Clearance form be signed by an authorized medical professional on an annual basis to ensure that participant are still eligible to participate in the longitudinal study.

Physician clearance is a requirement for participants deemed especially vulnerable by the IRB, as such, IRB representatives will have enhanced oversight of all studies requiring physician clearance.As part of the enhanced oversight, IRB representatives will conduct bi-annual either on-site or remote visits and request all physician clearance forms for review. The IRB retains the right to requests copies of physician clearance forms and other study materials at any point to ensure approved protocols are being adhered to for safety.

VI. Attachments

Physician Clearance Template

 

Topics: 

Release Info: 

02-02-2021

Changes to the Informed Consent

Summary of Changes

  •  [New] "Key information" to be presented at the beginning of the consent form
  • If you are collecting private information or identifiable biospecimens for future research you must include one of the following statements:
    • Identifiers might be removed and the de-identified information or biospecimens used for future research without additional informed consent from the subject.
    • The subject’s information or biospecimens will not be used or distributed for future research studies even if identifiers are removed.
  • Additional Elements of Informed Consent 46.116(c) - Three New Requirements (when appropriate)
  1. Biospecimens: a statement that biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
  2.  Clinically relevant results: a statement about whether clinically relevant research results, including individual research results, will be disclosed to subjects and if so, under what conditions.
  3.  Whole genome sequencing:  a statement about whether the research project might include whole genome sequencing.

UMass IRB/HRPO has updated the consent templates available on our webpages to reflect these changes.

Studies approved BEFORE January 21, 2019

  • Impact on Researchers: NONE
  • The new consent requirements will NOT be applicable.

Studies approved ON or AFTER January 21, 2019

  • Impact on Researchers: MINIMAL
  • The new consent requirements WILL BE applicable to all studies.
  • UMass IRB/HRPO will provide guidance regarding new requirements for consent documents during the IRB protocol review process.
  • UMass IRB/HRPO has updated the consent templates available on our webpage to reflect these changes (https://www.umass.edu/research/compliance/human-subjects-irb/forms).

Topics: 

Changes to the Exempt Categories

Summary of Changes

  • [Revised] Exempt Category 2(iii) has now been expanded to allow collection of potentially sensitive or harmful identifiable private information from adults if an IRB conducts a limited review* and determines that there are adequate provisions for protecting privacy and maintaining confidentiality

*The revised Common Rule allows for the exemption of research collecting identifiable information with the potential to cause harm if disclosed, provided that the IRB has determined that “there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data”. This new requirement is called a limited IRB review.

  • [New] Exempt Category 3 "Benign behavioral interventions*" such as solving puzzles or playing online games. Can also collect sensitive information with a limited IRB review

      *Benign behavioral interventions are defined as “brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing”.  Excludes physiological data collection methods (e.g., EEG, wearable devices such as FitBitTM, accelerometers, eye-tracking devices, blood pressure monitors, etc.)

  • [Revised] Exempt Category 4 (medical record review) can now be prospective as well
  • [New] Exempt categories 7 & 8 include limited reviews and Broad Consent.

Studies approved PRIOR to January 21, 2019

  • Impact on Researchers: NONE
  • UMass IRB/HRPO will continue to review all exempt protocols.
    A determination of "exempt" means the proposed research activity meets one of the exemption criteria and thus is exempt from the federal regulations that govern the conduct of human subjects research, Common Rule (45 CFR 46). However, a research activity determined as "Exempt", must still be reviewed by the IRB and conducted in accordance with the ethical principles outlined in the Belmont Report: respect fro persons, beneficence, and justice. Researchers must also comply with all applicable state and local regulations.

Studies approved ON or AFTER January 21, 2019

  • Impact on Researchers: NONE
  • The UMass IRB/HRPO will evaluate each submission and manually assign the applicable Exempt categories per the revised Common Rule. Meanwhile, the researchers should continue to select from the pre-2019 Exempt categories as listed in Kuali.

NOTES:

Please do NOT submit revisions to protocols reviewed under the "Expedited" categories to change the review category to "Exempt".

UMass IRB/HRPO reviews all exempt protocols and thus a review category re-assignment will not make any difference to the IRB protocol review process.

At this time UMass Amherst will not implement new Exempt categories 7 & 8 due to a possible increase in researcher's burden to track and store broad consents. This may change after additional guidance is provided by OHRP.

 

Topics: 

Changes to the Continuing Review Procedures

Summary of Changes

Continuing review is no longer required for some minimal risk research such as Exempt and Expedited studies that were approved on or after January 21, 2019 unless the IRB explicitly justifies for each study why continuing review would enhance protection of research subjects.

Continuing Review Procedure Changes – Impact on Researchers

FULL BOARD PROTOCOLS

  • Impact on Researchers: NONE
  • Continuing Review/Renewal -STILL REQUIRED (NO CHANGE)
  • Important: Continuing Review requirements for Full Board Protocols remain unchanged.

EXEMPT AND EXPEDITED PROTOCOLS

Studies approved PRIOR to January 21, 2019

  • Impact on Researchers: NONE
  • Continuing Review/Renewal -STILL REQUIRED (NO CHANGE)
  • Studies will continue to require submission of a renewal form annually until the study is completed at which time a final report form must be filed.

Studies approved ON or AFTER January 21, 2019

  • Impact on Researchers: MINIMAL
  • Continuing Review/Renewal - NOT REQUIRED (CHANGED)
  • Continuing review will no longer be required as a general practice unless the IRB reviewer explicitly justifies why continuing review would enhance protection of human research subjects. Your IRB approval letter will indicate the designation as requiring or not requiring a continuing review/renewal.

NOTE: UMASS/HRPO may re-evaluate its decision of not requiring continuing review/renewal for a particular study that was approved ON or AFTER January 21, 2019 based on changes proposed in a revision that increase the risk(s) to subjects, or as an outcome of the IRB's review of unanticipated problems/adverse events/research-related complaints.

UMASS/IRB/HRPO will notify the research if there is any change in the designation.
 

The following research team responsibilities remain unchanged (for both Exempt and Expedited Protocols)

  1. Complete a final report form when all participants have completed all research-related interventions AND you are only doing data analysis of de-identified data.

  2. Submit a revision in the following instances prior to implementation (unless to eliminate an apparent immediate hazard to subjects):

    • Enrollment of additional participants beyond the number approved

    • Any changes to study design/methodology, questionnaires, etc.

    • Any changes to study personnel

    • Any changes to consent procedures/documents

    • Any changes to recruitment procedures/materials

  3. Report the following to the IRB:

    • Unanticipated problems

    • Adverse Events

    • Research-related complaints

    • Protocol deviations/violations

 

 

Topics: 

New and Revised Definitions

Revised Human Subjects Definition

The definition of “human subject” has been changed to include “identifiable biospecimens” based upon how data and/or biospecimens have been collected or will be used.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (45 CFR 46.102(e) of the revised Common Rule)

Removal of four categories of activities from the definition of human subject research

The following activities are NOT considered to be human subject research:

  1. Scholarly and journalistic activities that focus directly on the specific individuals about whom the info is collected: (e.g., oral history, journalism, biography, legal criticism, legal research, and historical scholarship)

  2. Public health surveillance activities limited to those conducted, supported, requested, ordered, required, or authorized by a public health authority for public health importance (includes “timely situational awareness”)

  3. Criminal justice or criminal investigational purposes

  4. Authorized activities in support of intelligence, homeland security, defense, or other national security missions.

Addition of the definition of clinical trial

“Clinical trial” means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. (45 CFR 46.102(e) of the revised Common Rule).
 

Impact on Researchers: MINIMAL
UMASS IRB/HRPO has updated the guidance and forms to include the revised definition.

 

 

 

Topics: 

Certificate of Confidentiality (CoC)

Notice/Policy:  https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html

Summary: Effective October 1, 2017 CoCs will be issued automatically for any NIH-funded project using identifiable, sensitive information that was on-going on/after December 13, 2016

  • The CoC will be issued as a term and condition of award
  • There will be no physical certificate issued

To determine if this Policy applies to research conducted or supported by NIH, investigators will need to ask, and answer the following question:

  • Is the activity biomedical, behavioral, clinical, or other research?

If the answer to this question is no, then the activity is not issued a Certificate. If the answer is yes, then investigators will need to answer the following questions:

  • Does the research involve Human Subjects as defined by 45 CFR Part 46?
  • Are you collecting or using biospecimens that are identifiable to an individual as part of the research?
  • If collecting or using biospecimens as part of the research, is there a small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual?
  • Does the research involve the generation of individual level, human genomic data?

If the answer to any one of these questions is yes, then this Policy will apply to the research

Certificate of Confidentiality Assurance Template (required as a part of the CoC application)

https://humansubjects.nih.gov/coc/assurance-template

Suggested Language regarding CoC for Consent Document: (https://humansubjects.nih.gov/coc/suggested-consent-language )

Suggested consent language:

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects. 

[Use the following language as applicable] The Certificate cannot be used to refuse a request for information from personnel of the United States federal or state government agency sponsoring the project that is needed for auditing or program evaluation by [THE AGENCY] which is funding this project or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).  You should understand that a Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it.

[language such as the following should be included if researcher intends to disclose  information covered by a Certificate, such as potential child abuse, or intent to hurt self or others in response to specific federal, state, or local laws.] The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law of [list what will be reported, such as child abuse and neglect, or harm to self or others]. 

[language such as the following should be included if researcher intends to disclose information covered by a Certificate, with the consent of research participants.] The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to in this informed consent document [restate what will be disclosed, such as including research data in the medical record].

** Please note that information listed here is subject to change based on additional guidance by NIH. Please continue to monitor this page for additional/updated guidance from NIH.**

Topics: 

Single IRB (sIRB) Policy for Multi-site Research

Single IRB Policy: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html

Frequently Asked Questions on Use of a Single IRB for Multi-Site Research Costs: https://osp.od.nih.gov/clinical-research/nih-policy-on-the-use-of-a-single-irb-for-multi-site-research-faqs-on-costs/

Frequently Asked Questions on Implementation of the Single IRB Policy: https://osp.od.nih.gov/clinical-research/implementation-of-the-sirb-policy/

For applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects.

This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research. It does not apply to career development, research training or fellowship awards. Implementation of the NIH sIRB policy is expected to reduce unnecessary administrative burdens and systemic inefficiencies while maintaining appropriate human subjects protections.

Applicants will be expected to include a plan for the use of a sIRB in the grant applications and contract proposals they submit to the NIH (for due dates on or after January 25, 2018).

The NIH single IRB policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.

The NIH single IRB policy does not apply to studies conducted under career development, research training or fellowship awards. Under the policy, “multi-site” is defined as two or more sites. Foreign sites participating in NIH- funded, multi-site studies will not be expected to follow this policy.

The NIH single IRB policy applies to multi-site human subjects research regardless of the funding mechanism (e.g., grants, cooperative agreements, contracts or other mechanisms such as Cooperative Research and Development Agreements (CRADAs), and Interagency Agreements (IAA)). The policy applies whether the sites are subawards to a primary award recipient or separate awards are made for participating sites. The NIH Single IRB policy does not apply to Other Transaction Agreements (OTAs).

** Please note that information listed here is subject to change based on additional guidance by NIH. Please continue to monitor this page for additional/updated guidance from NIH.**

Topics: 

Please remember to download the expanded guidance document linked on the right side of this webpage. The expanded guidance document outlines the following items:

NIH Revisions to the Policies on Definition of a Clinical Trial 

  1. Revised NIH Definition of Clinical Trial
  2. Determination If Your Human Subject’s Research Study Meets the Revised NIH Definition of a Clinical Trial?
  3. Good Clinical Practice (GCP) Training
  4. Data and Safety Monitoring of Clinical Trials
  5. Dissemination of NIH-Funded Clinical Trial Information

** Please note that information listed here is subject to change based on additional guidance by NIH. Please continue to monitor this page for additional/updated guidance from NIH.**

Document File: 

Topics: 

Pages